Codeine Concerns Cough Up FDA's OTC Monograph Problems

FDA recently ordered label changes for Rx codeine drugs but could do nothing immediately and directly to affect marketing of OTC monograph drugs containing the ingredient. This disconnect provides more evidence that FDA should be empowered with flexibility to address these kinds of situations, as it can for prescription drugs, consumer health industry stakeholders say.

Additionally, the Pew Charitable Trusts suggests the case is clearly made for establishing user fees to support FDA’s work in determining whether drug ingredients are safe and effective for a...